Consumer Access to Personal Health Information for Asthma Self-Management (ASMA)

Consumer Access to Personal Health Information for Asthma Self-Management Phase 2 (Pilot Implementation)

This study is to compare Smart phone mobile device and/or web based application asthma action plan to the standard of care paper based asthma action plan within an asthma program. The Primary hypothesis: Health Outcome - The Breathe mobile health and web-based application improves asthma related quality of life more than conventional best practice

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Behavioral: mobile & web-based action plan

Detailed Description

This study is a multi-centre, randomized controlled trial comparing a web-based (Smart phone mobile device, tablet and/or personal computer PC) asthma action plan application to best practice/usual care within an asthma program. A third external comparator arm will compare participants to all patients with asthma in Ontario using data obtained from the Ontario Asthma Surveillance Information System (OASIS) cohort, created from administrative data sets within the Institute for Clinical Evaluative Sciences (ICES). Subjects will be randomly assigned in blocks of four, stratified by site to, in a ratio of 1:1 intervention or control arms. The study will enrol approximately 400 patients in total at all study sites.

• Study Type: Interventional
• Enrollment (Actual): 344
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Amherstburg, Ontario, Canada
      • Amherstburg FHT
    • Chatham, Ontario, Canada
      • Chatham-Kent FHT
    • Harrow, Ontario, Canada
      • Harrow FHT
    • Kingston, Ontario, Canada
      • Kingston Hospital Asthma Clinic
    • Leamington, Ontario, Canada, N8H 1N8
      • Leamington FHT
    • London, Ontario, Canada
      • St. Joseph's Hospital Asthma Clinic
    • Sault Ste. Marie, Ontario, Canada
      • Sault St. Marie Group Health Centre
    • Windsor, Ontario, Canada
      • Windsor FHT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Diagnosis of asthma
• Age 18 of age or older
• Familiar with web technology
• Provide consent
• Understand/read/write English

Exclusion Criteria:

- Indication of other chronic lung diseases in the opinion of the physician that would impact their ability to participate in the trial or affect quality of life (Cystic Fibrosis, Chronic Obstructive Pulmonary Disease, Bronchiectasis)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Written self-management action plan; Usual Care: Evidence-based best practice within the primary care asthma program including written self-management action plan and regular clinical review.	Behavioral: mobile & web-based action plan; Evidence-based best practice primary care asthma program including asthma self-management education replacing the written self-management action plan with the Breathe mobile health and web-based application
Experimental: mobile & web based action plan; Evidence-based best practice within the primary care asthma program, replacing the written action plan with the Breathe mobile health and web-based application.	Behavioral: mobile & web-based action plan; Evidence-based best practice primary care asthma program including asthma self-management education replacing the written self-management action plan with the Breathe mobile health and web-based application
No Intervention: Administrative data set; Health services use will be evaluated comparatively against our intervention population and our control and we will include health services utilization data from one year prior randomization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health Outcome - Quality of Life	Health Outcome - The Breathe mobile health and web-based application improves asthma related quality of life more than conventional best practice.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality - Health Care Utilization	Appropriateness of Care - Individuals with asthma who use the intervention will experience a decrease in the number of unplanned health system encounters	1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health Outcome - Quality	Improvements in symptom profile greater than conventional best practice.	1 year
Health Outcome - Quality of Life	Per protocol evaluation of the primary outcome, quality of life. It is anticipated that some subjects randomized to the intervention arm will not use the smartphone application. We seek to evaluate the primary outcome in those subjects who were adherent to the application compared to control subjects.	6 months

Collaborators and Investigators

• Sponsor: Lawson Health Research Institute
• Collaborators: Ontario Ministry of Health and Long Term Care; Ontario Lung Association; Canada Health Infoway; TELUS
• Investigators: Principal Investigator: Christopher Licskai, Lawson Health Research Institution

Publications and helpful links

General Publications

• Morita PP, Yeung MS, Ferrone M, Taite AK, Madeley C, Stevens Lavigne A, To T, Lougheed MD, Gupta S, Day AG, Cafazzo JA, Licskai C. A Patient-Centered Mobile Health System That Supports Asthma Self-Management (breathe): Design, Development, and Utilization. JMIR Mhealth Uhealth. 2019 Jan 28;7(1):e10956. doi: 10.2196/10956.

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: January 21, 2013
• First Submitted That Met QC Criteria: October 14, 2013
• First Posted (Estimate): October 17, 2013

Study Record Updates

• Last Update Posted (Actual): August 19, 2019
• Last Update Submitted That Met QC Criteria: August 15, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: 00000940